scholarly journals Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

2020 ◽  
Author(s):  
Miloš Bjelović ◽  
László Harsányi ◽  
Áron Altorjay ◽  
Zsolt Kincses ◽  
Peter Forsell
Keyword(s):  
Adverse Events ◽  
Clinical Investigation ◽  
Ph Monitoring ◽  
Acid Reflux ◽  
Total Acid ◽  
Serious Adverse Events ◽  
Hrql Score ◽  
New Device ◽  
Dynamic Treatment

Abstract BACKGROUND RefluxStop™ is an implantable, non-active, single use device to be used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS In prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD had been included. They were operated using standardized surgical technique between December 2016 and September 2017 and followed up for one year (CE-mark investigation 6-months). Primary safety outcome was the prevalence of serious adverse events related to the device and primary effectiveness outcome reduction of GERD symptoms based on the GERD HRQL score. Secondary outcomes were the prevalence of the adverse events apart from serious, reduction of the total acid exposure time on 24-hour pH monitoring, reduction in average daily PPI dosage and subject satisfaction. RESULTS There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p<0.001). 24-h pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH<4 from 16.35% to 0.80% at the 6-month visit (p<0.001). At 1-year: No new cases of dysphagia were recorded, occurred in 2 subjects, both significantly reduced compared to baseline. Regular daily PPI use before surgery occurred in all 50 subjects. At the 1-year follow-up only 1 subject took regular daily PPIs due to too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects. CONCLUSION The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow up visit, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced.

scholarly journals Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

2020 ◽  
Author(s):  
Miloš Bjelović ◽  
László Harsányi ◽  
Áron Altorjay ◽  
Zsolt Kincses ◽  
Peter Forsell
Keyword(s):  
Adverse Events ◽  
Clinical Investigation ◽  
Ph Monitoring ◽  
Acid Reflux ◽  
Total Acid ◽  
Serious Adverse Events ◽  
Hrql Score ◽  
New Device ◽  
Dynamic Treatment

Abstract BACKGROUND RefluxStop™ is an implantable, non-active, single use device used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original, anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS In a prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD were operated using a standardized surgical technique between December 2016 and September 2017. They were followed up for one year (CE-mark investigation 6-months). Primary safety outcome was prevalence of serious adverse events related to the device, and primary effectiveness outcome reduction of GERD symptoms based on GERD-HRQL score. Secondary outcomes were prevalence of adverse events other than serious adverse events, reduction of total acid exposure time in 24-hour pH monitoring, and reduction in average daily PPI usage and subject satisfaction. RESULTS There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p<0.001). 24-hour pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH<4 from 16.35% to 0.80% at the 6-month visit (p<0.001), with 98% of subjects showing normal 24-hour pH. At 1 year: No new cases of dysphagia were recorded, present in 2 subjects, which existed already at baseline. Regular daily PPI usage occurred in all 50 subjects at baseline. At 1-year follow-up, only 1 subject took regular daily PPIs due to a too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects.CONCLUSION The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow-up, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced.

scholarly journals Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

2020 ◽  
Author(s):  
Miloš Bjelović ◽  
László Harsányi ◽  
Áron Altorjay ◽  
Zsolt Kincses ◽  
Peter Forsell
Keyword(s):  
Adverse Events ◽  
Clinical Investigation ◽  
Ph Monitoring ◽  
Acid Reflux ◽  
Total Acid ◽  
Serious Adverse Events ◽  
Hrql Score ◽  
New Device ◽  
Dynamic Treatment

Abstract BACKGROUND RefluxStop™ is an implantable, non-active, single use device to be used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS In prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD had been included. They were operated using standardized surgical technique between December 2016 and September 2017 and followed up for one year (CE-mark investigation 6-months). Primary safety outcome was the prevalence of serious adverse events related to the device and primary effectiveness outcome reduction of GERD symptoms based on the GERD HRQL score. Secondary outcomes were the prevalence of the adverse events apart from serious, reduction of the total acid exposure time on 24-hour pH monitoring, reduction in average daily PPI dosage and subject satisfaction. RESULTS There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p<0.001). 24-h pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH<4 from 16.35% to 0.80% at the 6-month visit (p<0.001). At 1-year: No new cases of dysphagia were recorded, occurred in 2 subjects, both significantly reduced compared to baseline. Regular daily PPI use before surgery occurred in all 50 subjects. At the 1-year follow-up only 1 subject took regular daily PPIs due to too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects. CONCLUSION The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow up visit, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced.

scholarly journals Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

2020 ◽  
Author(s):  
Miloš Bjelović ◽  
László Harsányi ◽  
Áron Altorjay ◽  
Zsolt Kincses ◽  
Peter Forsell
Keyword(s):  
Adverse Events ◽  
Clinical Investigation ◽  
Ph Monitoring ◽  
Acid Reflux ◽  
Total Acid ◽  
Serious Adverse Events ◽  
Hrql Score ◽  
New Device ◽  
Dynamic Treatment

Abstract BACKGROUND RefluxStop™ is an implantable, non-active, single use device to be used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS In prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD had been included. They were operated using standardized surgical technique between December 2016 and September 2017 and followed up for one year (CE-mark investigation 6-months). Primary safety outcome was the prevalence of serious adverse events related to the device and primary effectiveness outcome reduction of GERD symptoms based on the GERD HRQL score. Secondary outcomes were the prevalence of the adverse events apart from serious, reduction of the total acid exposure time on 24-hour pH monitoring, reduction in average daily PPI dosage and subject satisfaction. RESULTS There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p<0.001). 24-h pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH<4 from 16.35% to 0.80% at the 6-month visit (p<0.001). At 1-year: No new cases of dysphagia were recorded, occurred in 2 subjects, both significantly reduced compared to baseline. Regular daily PPI use before surgery occurred in all 50 subjects. At the 1-year follow-up only 1 subject took regular daily PPIs due to too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects. CONCLUSION The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow up visit, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced.

scholarly journals Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures

2021 ◽  
Author(s):  
Douglas M. Sidle ◽  
Pablo Stolovitzky ◽  
Ellen M. O'Malley ◽  
Randall A. Ow ◽  
Nathan E. Nachlas ◽  
...  
Keyword(s):  
Adverse Events ◽  
Nasal Obstruction ◽  
Large Population ◽  
Inferior Turbinate ◽  
Nasal Valve ◽  
Serious Adverse Events ◽  
Vas Scores ◽  
Nasal Implant ◽  
Nasal Valve Collapse

AbstractThe aim of the study is to report outcomes after treatment of nasal valve collapse with a bioabsorbable nasal implant. It involves two prospective, multicenter, post-market studies evaluating long-term effectiveness of the LATERA implant for severe to extreme nasal obstruction. Participants underwent implant alone or with concomitant inferior turbinate reduction (ITR) and/or septoplasty. Outcome measures included the change from baseline Nasal Obstruction Symptom Evaluation (NOSE) scores, NOSE responder rates, visual analog scale (VAS) scores, and adverse events. A total cohort of 277 participants (109 implants only, 67 implants + ITR, 101 implants + septoplasty + ITR) enrolled at 19 U.S. centers was available for analysis with 177 participants (69 implants only, 39 implants + ITR, 69 implants + septoplasty + ITR) available at 2 years. The mean changes from baseline in NOSE scores and VAS scores were statistically significant (p < 0.001) at all follow-up periods. The baseline NOSE score of 77.8 ± 13.6 was improved to 24.2 ± 23.6 at 24 months. Greater than 90% of participants were NOSE responders across all follow-up periods, 6.1% withdrew for lack of treatment effect. The baseline VAS score of 66.7 ± 18.8 was improved to 21.1 ± 23.9 at 24 months. There were no serious adverse events related to the device or implant procedure. Implant retrieval rate was 4.0% (22/543 implants). Nonserious adverse events were mild to moderate in severity, typically occurred within 6 months of implant, and resolved or were stable. Significant reductions in NOSE and VAS scores and high responder rates from our large population of patients with nasal obstruction who had nasal valve implants confirm sustained effectiveness at 24 months after treatment. The studies are registered on www.clinicaltrials.gov (NCT02952313 and NCT02964312).

scholarly journals POS0647 EFFICACY, SAFETY AND CHARACTERISTICS OF IGURATIMOD-BASED THERAPY IN THE TREATMENT OF UA, ERA AND RA PATIENTS FOR 24 WEEKS: A PROSPECTIVE COHORT STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 561.2-562
Author(s):  
X. Liu ◽  
Z. Sun ◽  
W. Guo ◽  
F. Wang ◽  
L. Song ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cohort Study ◽  
Adverse Events ◽  
Disease Activity ◽  
Prospective Cohort Study ◽  
Early Rheumatoid Arthritis ◽  
Prospective Cohort ◽  
Combined Treatment ◽  
Serious Adverse Events

Background:Experts emphasize early diagnosis and treatment in RA, but the widely used diagnostic criterias fail to meet the accurate judgment of early rheumatoid arthritis. In 2012, Professor Zhanguo Li took the lead in establishing ERA “Chinese standard”, and its sensitivity and accuracy have been recognized by peers. However, the optimal first-line treatment of patients (pts) with undifferentiated arthritis (UA), early rheumatoid arthritis (ERA), and rheumatoid arthritis (RA) are yet to be established.Objectives:To evaluate the efficacy and safety of Iguratimod-based (IGU-based) Strategy in the above three types of pts, and to explore the characteristics of the effects of IGU monotherapy and combined treatment.Methods:This prospective cohort study (ClinicalTrials.gov Identifier NCT01548001) was conducted in China. In this phase 4 study pts with RA (ACR 1987 criteria[1]), ERA (not match ACR 1987 criteria[1] but match ACR/EULAR 2010 criteria[2] or 2014 ERA criteria[3]), UA (not match classification criteria for ERA and RA but imaging suggests synovitis) were recruited. We applied different treatments according to the patient’s disease activity at baseline, including IGU monotherapy and combination therapies with methotrexate, hydroxychloroquine, and prednisone. Specifically, pts with LDA and fewer poor prognostic factors were entered the IGU monotherapy group (25 mg bid), and pts with high disease activity were assigned to combination groups. A Chi-square test was applied for comparison. The primary outcomes were the proportion of pts in remission (REM)or low disease activity (LDA) that is DAS28-ESR<2.6 or 3.2 at 24 weeks, as well as the proportion of pts, achieved ACR20, Boolean remission, and good or moderate EULAR response (G+M).Results:A total of 313 pts (26 pts with UA, 59 pts with ERA, and 228 pts with RA) were included in this study. Of these, 227/313 (72.5%) pts completed the 24-week follow-up. The results showed that 115/227 (50.7%), 174/227 (76.7%), 77/227 (33.9%), 179/227 (78.9%) pts achieved DAS28-ESR defined REM and LDA, ACR20, Boolean remission, G+M response, respectively. All parameters continued to decrease in all pts after treatment (Fig 1).Compared with baseline, the three highest decline indexes of disease activity at week 24 were SW28, CDAI, and T28, with an average decline rate of 73.8%, 61.4%, 58.7%, respectively. Results were similar in three cohorts.We performed a stratified analysis of which IGU treatment should be used in different cohorts. The study found that the proportion of pts with UA and ERA who used IGU monotherapy were significantly higher than those in the RA cohort. While the proportion of triple and quadruple combined use of IGU in RA pts was significantly higher than that of ERA and UA at baseline and whole-course (Fig 2).A total of 81/313 (25.8%) pts in this study had adverse events (AE) with no serious adverse events. The main adverse events were infection(25/313, 7.99%), gastrointestinal disorders(13/313, 4.15%), liver dysfunction(12/313, 3.83%) which were lower than 259/2666 (9.71%) in the previous Japanese phase IV study[4].The most common reasons of lost follow-up were: 1) discontinued after remission 25/86 (29.1%); 2) lost 22/86 (25.6%); 3) drug ineffective 19/86 (22.1%).Conclusion:Both IGU-based monotherapy and combined therapies are tolerant and effective for treating UA, ERA, and RA, while the decline in joint symptoms was most significant. Overall, IGU combination treatments were most used in RA pts, while monotherapy was predominant in ERA and UA pts.References:[1]Levin RW, et al. Scand J Rheumatol 1996, 25(5):277-281.[2]Kay J, et al. Rheumatology 2012, 51(Suppl 6):vi5-9.[3]Zhao J, et al. Clin Exp Rheumatol 2014, 32(5):667-673.[4]Mimori T, et al. Mod Rheumatol 2019, 29(2):314-323.Disclosure of Interests:None declared

scholarly journals Efficacy and safety of combined endoscopic cyanoacrylate injection and balloon-occluded retrograde transvenous occlusion (BRTOcc) of gastrorenal shunts in patients with bleeding gastric fundal varices

2020 ◽  
Author(s):  
Fateh Bazerbachi ◽  
Akira Dobashi ◽  
Swarup Kumar ◽  
Sanjay Misra ◽  
Navtej S Buttar ◽  
...  
Keyword(s):  
Adverse Events ◽  
Gastric Varices ◽  
High Rate ◽  
Efficacy And Safety ◽  
Cyanoacrylate Glue ◽  
Serious Adverse Events ◽  
Gastroesophageal Varices ◽  
Life Threatening ◽  
Glue Embolization

Abstract Background Endoscopic cyanoacrylate (glue) injection of fundal varices may result in life-threatening embolic adverse events through spontaneous gastrorenal shunts (GRSs). Balloon-occluded retrograde transvenous occlusion (BRTOcc) of GRSs during cyanoacrylate injection may prevent serious systemic glue embolization through the shunt. This study aimed to evaluate the efficacy and safety of a combined endoscopic–interventional radiologic (BRTOcc) approach for the treatment of bleeding fundal varices. Methods We retrospectively analysed the data of patients who underwent the combined procedure for acutely bleeding fundal varices between January 2010 and April 2018. Data were extracted for patient demographics, clinical and endoscopic findings, technical details, and adverse events of the endoscopic–BRTOcc approach and patient outcomes. Results We identified 30 patients (13 [43.3%] women; median age 58 [range, 25–92] years) with gastroesophageal varices type 2 (53.3%, 16/30) and isolated gastric varices type 1 (46.7%, 14/30) per Sarin classification, and median clinical and endoscopic follow-up of 151 (range, 4–2,513) days and 98 (range, 3–2,373) days, respectively. The median volume of octyl-cyanoacrylate: Lipiodol injected was 7 (range, 4–22) mL. Procedure-related adverse events occurred in three (10.0%) patients, including transient fever, non-life-threatening pulmonary glue embolism, and an injection-site ulcer bleed. Complete gastric variceal obturation was achieved in 18 of 21 patients (85.7%) at endoscopic follow-up. Delayed variceal rebleeding was confirmed in one patient (3.3%) and suspected in two patients (6.7%). Although no procedure-related deaths occurred, the overall mortality rate was 46.7%, primarily from liver-disease progression and co-morbidities. Conclusion The combined endoscopic–BRTOcc procedure is a relatively safe and effective technique for bleeding fundal varices, with a high rate of variceal obturation and a low rate of serious adverse events.

scholarly journals Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

2021 ◽  
Author(s):  
Ilkka Rauma ◽  
Tiina Mustonen ◽  
Juha Matti Seppä ◽  
Maritta Ukkonen ◽  
Marianne Männikkö ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Case Series ◽  
Retrospective Case ◽  
Serious Adverse Events ◽  
Highly Active ◽  
Disease Modifying Therapy ◽  
Case Series Study ◽  
Multiple Sclerosis Patients

Abstract Background Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. Objectives To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. Methods In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. Results Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1–3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. Conclusions SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.

Efficacy, Safety and Tolerability Of Valsartan Plus HCTZ in Patients With Essential Hypertension: A Multicentre Observational Study in Bangladesh

1970 ◽  
Vol 3 (1) ◽  
pp. 37-44
Author(s):  
MN Islam
Keyword(s):  
Adverse Event ◽  
Essential Hypertension ◽  
Adverse Events ◽  
Global Assessment ◽  
Paired Comparison ◽  
Additional Treatment ◽  
Serious Adverse Events ◽  
Published Evidence ◽  
Bangladeshi Population

Background: Valsartan is an established drug for treatment of essential hypertension. It blocks the action of Angiotensin II irrespective of its sources. A large proportion of patients need additional treatment with two or more drugs of different pharmacological classes for achieving target blood pressure. Published evidence demonstrated synergistic effect of Thiazides with ARB. Coadministration of valsartan and Hydrochlorothiazide has the potential to reverse the untoward effect of each other. Current study aimed at evaluating the efficacy, safety and tolerability of Valsartan plus Hydrochlorothiazide combination, and thus validating the regimen in the treatment of essential hypertension in Bangladeshi population, a population significantly different from Caucasian population where most studies were done. Methods: Current study is a prospective interventional study involving 404 Adult, patients, with Stage I (SBP 140-159 mmHg/DBP 90-99 mmHg) or Stage II (SBP≥160 mmHg/DBP ≥100 mmHg) essential hypertension or patients uncontrolled on current mono-therapy or other combination therapy. Valsartan plus HCTZ 80/12.5 mg once daily tablet were prescribed to continue till the following visit or for the remainder of the study. In case of inadequate control increment in dose was made on the following visit. Patients were assessed at baseline, at 4th weeks, 12th week and 24th week. One of the major outcome parameter set for the study was the percentage of participant having BP controlled that is a SBP <140 mmHg and DBP <90 mmHg or a reduction >10 mmHg for DBP and/ or >20 mmHg SBP versus baseline values at 24 weeks. At final follow-up, in addition to repetition of the baseline measurements and examinations, data on Safety of the drug was collected by enquiring and recording all adverse events or serious adverse events. Global assessment of efficacy and tolerability of treatment was also done by both the physicians and patients on a 4-point scale. Result: The percentage of participant having BP controlled at the end of the trial was 91%. Besides, Significant reduction in mean SBP and mean DBP was also evident (P<.001) through paired comparison from baseline to end of the study. Average reduction of 32.4 ± 19.5 mmHg was seen in systolic BP and 17.4 ± 9.3 mmHg in diastolic BP. Global assessment based on both physician and patients reported greater satisfaction with the efficacy of treatment modality. Total adverse event reported by only six (1.5%) participants. Of the six cases three of the adverse effect was reported at 3rd visit and another three were reported at 4th visit. Total five dropouts (1.24%) were reported of which 1 in 3rd visit and 4 in 4th visit. Among the dropout patient three were withdrawn from the study and two didn’t attend the final follow-up. Global assessment of safety and tolerability based on both physician and patient’s opinion reveals greater satisfaction level with the safety and tolerability of combination treatment. Conclusion: The combination of valsartan and hydrochlorothiazide is an effective treatment for patients with essential hypertension. The combination is also effective in patients not responding to monotherapy with either agent. The drug is found to be well tolerated with minimal adverse event during the course of treatment. Key words: Valsartan; Hydrochlorothiazide; Hypertension. DOI: 10.3329/cardio.v3i1.6425Cardiovasc. j. 2010; 3(1): 37-44

scholarly journals Navigating the Quagmire: Comparison and Interpretation of COVID-19 Vaccine Phase 1/2 Clinical Trials

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 746
Author(s):  
Luca Tudor Giurgea ◽  
Matthew James Memoli
Keyword(s):  
Adverse Events ◽  
Protective Efficacy ◽  
Phase 1 ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Safety Studies ◽  
Antibody Titers ◽  
Public Health Strategies

Vaccines against Coronavirus Disease 2019 Originated-19) have been developed with unprecedented rapidity, many utilizing novel strategies. As of November 2020, a series of publications have outlined the results of phase 1/2 studies of nine different vaccines planned to move forward to phase 3 trials. The results are encouraging, demonstrating a paucity of severe or serious adverse events and robust induction of antibody titers. Determination of the vaccine candidates with the highest protective efficacy and best adverse event profiles will be essential in refining public health strategies. However, differences in study design and reporting of data make comparisons of existing phase 1/2 studies difficult. With respect to safety, studies have variable follow-up times and may use different definitions for adverse events. Immunogenicity outcomes are even more inconsistent, with variations in timepoints and critical differences in the types of antibodies studied as well as methodological differences in assays. Furthermore, the correlates of protection in COVID-19 are not known. Harmonization of phase 3 trial designs and use of objective and meaningful clinical outcomes will be crucial in streamlining future global responses to the pandemic.

A Nationwide Investigation of a Possible Protamine Drug-Product Defect

1992 ◽  
Vol 26 (5) ◽  
pp. 643-644 ◽  
Author(s):  
Carlos R. Herrera ◽  
Thaddeus H. Grasela ◽  
Cynthia A. Walawander
Keyword(s):  
Coronary Artery ◽  
Adverse Events ◽  
Coronary Artery Bypass ◽  
Response Rate ◽  
Artery Bypass ◽  
Drug Surveillance ◽  
Surveillance Network ◽  
Serious Adverse Events ◽  
Telephone Interviews

OBJECTIVE: To follow-up a report submitted to FDA Spontaneous Reporting System, we investigated the hypothesis that there was not a striking increase in unexpected deaths within four hours after elective coronary artery bypass surgery associated with protamine sulfate use. DESIGN: Surveys were mailed to clinical pharmacists at 521 hospitals participating in the Drug Surveillance Network. Questionnaires were to be completed with the assistance of cardiac surgeons and anesthesiologists. Hospitals responding with a suspected problem with protamine were contacted via telephone. RESULTS: Surveys were received from clinical pharmacists at 380 hospitals (73 percent response rate) and 29 hospitals reported the occurrence of potential problems associated with protamine during coronary artery bypass graft surgery. Telephone interviews of the positive responders yielded six cases of possible myocardial decomposition potentially associated with protamine. There was no association with a specific distributor, however, and none of the hospitals reported a dramatic increase in serious adverse events around the time of index cases. CONCLUSIONS: There was no evidence of a widespread public health problem with protamine and a product recall was not necessary. The high response rate and the ability to follow-up with telephone interviews suggests that the Drug Surveillance Network is an effective mechanism for investigating possible outbreaks of serious adverse events in the hospital setting.

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